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VSV-ZEBOV Geneva Vaccine Trial

NCT02287480 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2023-05-10

Study results available
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Summary

The hemorrhagic fever resulting from Ebola infection is frequently fatal; the current Ebola outbreak, still in its ascendant phase, has a mortality rate over 50%. There is no proven therapy or prevention available at this time.

The vaccine candidate VSV-ZEBOV (BPSC1001) has shown promising safety and efficacy in preventing Ebola Zaire infections in non-human primates (NHP). Before it can be assessed in large Phase IIb/3 trials in affected areas, safety data from phase 1 first-in-human trials are needed. To accelerate this process, the World Health Organization (WHO) has constituted a consortium of Clinical Research Centers in Switzerland, Germany, and Africa that will use similar protocols to collectively include roughly 250 volunteers, the sample size required to identify a 2-fold difference in anti-ZEBOV IgG antibody titers following immunization with 2 different doses of BPSC1001.

The joint primary objectives of this single-center, double-blind, randomized placebo-controlled phase 1 dose-finding study are to assess the safety and tolerability of the VSV-ZEBOV vaccine when administered to healthy volunteers at a lower or higher vaccine dose and to define whether seroresponses differ significantly following immunization with the lower or higher vaccine dose.

Conditions

  • Ebolavirus Disease

Interventions

BIOLOGICAL

VSV-ZEBOV

See arm/group descriptions.

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Wellcome Trust

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • Philipps University Marburg

    collaborator OTHER

  • Albert Schweitzer Hospital

    collaborator OTHER

  • Institute of Tropical Medicine, University of Tuebingen

    collaborator OTHER

  • KEMRI-Wellcome Trust Collaborative Research Program

    collaborator OTHER

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Claire-Anne Siegrist, MD · University Hospita, Geneva

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-04-30
Completion
2016-01-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02287480 on ClinicalTrials.gov